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Related keywords
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Specialist, Manufacturing Jobs
Company | Moderna |
Address | Norwood, MA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-09-03 |
Posted at | 9 months ago |
The Role:
- Participates in equipment start-up, commissioning, and validation activities
- Creates and presents trending and metrics reports
- Ensures equipment operational readiness
- Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion
- Subject matter expert for a processing technology (chromatography, filtrations, digital systems, etc…)
- Conducts complex document revisions and/or document management including batch production records and manufacturing procedures
- Manufacturing lead for tech transfers and other projects
- Works to optimize, trend, and report manufacturing process operational parameters during routine manufacturing campaigns
- Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
- Performs training with staff on the floor
- Facilitate cross functional teams to drive complex manufacturing operations changes or improvements
- Works independently with minimal supervision and direction
- Participates in defining robust process parameters during routine manufacturing campaigns
- Assists with troubleshooting in case of equipment failure, including impact assessment of out-of-tolerance records as needed
- Participates or leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
- Practices and promotes safe work habits and adheres to safety procedures and guidelines
- Monitor process operations to ensure compliance with specifications.
- Assists with deviation investigations as the pertain to processing technology expertise and related equipment or materials
- Utilizes manufacturing process knowledge to drive continuous improvement in process operations
- Project management experience
- Minimum of 1 years’ experience with deviation/investigation management systems or a similar technical writing system in a cGMP environment
- Bachelor's Degree with 5+ years of experience in biopharmaceutical operations Degree in Engineering or Life Sciences is preferred.
- Demonstrated ability to lead cross functional teams and deliver results with minimal supervision
- Knowledge in biologics drug substance purification operations (chromatography, TFF, aseptic technique) or a similar complex specialized environment
- Background in lean manufacturing methodologies and operational excellence
- Ability to manage multiple competing priorities in a fast-paced environment
- Excellent written and oral English language skills
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Paid sabbatical after 5 years; every 3 years thereafter
- Adoption and family-planning benefits
- Free parking or subsidized commuter passes
- Generous paid time off, including:
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- Vacation, sick time and holidays
- 401k match and Financial Planning tools
- Dedicated care coordination support for our LGBTQ+ community
- Highly competitive and inclusive medical, dental and vision coverage options
- Volunteer time to participate within your community
- Free premium access to fitness, nutrition, and mindfulness classes
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Discretionary year-end shutdown
- Location-specific perks and extras!
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Exclusive preferred pricing on Peloton fitness equipment
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